Valsartan, Aliskiren Hemifumarate Oral tablet
What is this medicine?
ALISKIREN; VALSARTAN (a lis KYE ren; val SAR tan) is a combination of a renin inhibitor and an angiotensin II antagonist. It is used to treat high blood pressure.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual or allergic reaction to aliskiren, valsartan, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on your prescription label. You may take this medicine with or without food, but try to take it the same way every time. Take your doses at regular intervals. Do not take more medicine than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
diuretics, especially triamterene, spironolactone or amiloride
other medicines for high blood pressure
salt substitutes with potassium
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Check your blood pressure as directed. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her.
Do not take this medicine if you have diabetes. Talk to your doctor or health care professional for more information.
Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.
Avoid salt substitutes unless you are told otherwise by your doctor or health care professional.
Do not treat yourself for coughs, colds, or pain while you are taking this medicine without asking your doctor or health care professional for advice. Some ingredients may increase your blood pressure.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash or hives, swelling of the hands, feet, face, lips, throat, or tongue
fast, irregular heartbeat
feeling faint or lightheaded, falls
fever or sore throat
low blood pressure
pain, tingling, numbness in the hands or feet
skin rash, itching
trouble passing urine or change in the amount of urine
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
change in sex drive or performance
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert